Citicoline In Traumatic Brain Injury "CITBRAIN"

Completed

Phase N/A Results N/A

Trial Description

To assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.

Interventions

  • Citicoline (CerAxon®)Drug
    Other Names: CDP-choline
    Intervention Desc: Phosphatidylcholine precursor, membrane stabilizer (cytidyl diphosphocholine)
  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.

Trial Design

Interventional, Treatment, Prospective, Randomized, Placebo Control, Parallel Assignment, Efficacy Study.

Patient Involvement

Patients will be randomized to either the intervention group or the placebo group. The interventional group will take Citicoline (Phosphatidylcholine precursor, membrane stabilizer) intravenously 1gm BD for 7 days followed by 500 mg BD oral for 2 months. The placebo group will receive Multivitamin IV for 7 days and then orally for 2 months. Then they will be given Modified Rankin test for disability and Glasgow Outcome Score at the end of 90 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Survival, rate of recovery, toxicity.
Secondary Modified Rankin test for disability and Glasgow Outcome Score. [Outcome at the end of 90 days].

Sponsors

Elder pharmaceuticals limited Ferrer Grupo, Barcelona Spain